Hemostatic compositions, devices, and methods

ABSTRACT

Compositions that include a clay such as kaolin dispersed in a liquid such as water may be useful for promoting the clotting of blood. The compositions may be in a liquid, gel, paste, foam, or another form. Uses may include treating a traumatic injury such as in injury caused by a bullet, an explosive, a blade etc., or an injury caused during a medical procedure such as surgery.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/995,592, filed Jan. 14, 2016, now pending, which is acontinuation of U.S. patent application Ser. No. 14/479,214, filed Sep.5, 2014, abandoned, which is a continuation of U.S. patent applicationSer. No. 13/240,795, filed Sep. 22, 2011, now U.S. Pat. No. 8,858,969,which claims the priority benefit of U.S. Patent Application No.61/385,388, filed Sep. 22, 2010. These applications and any otherapplications for which a foreign or domestic priority claim isidentified in the Application Data Sheet filed with the presentapplication are hereby incorporated by reference for all purposes intheir entireties herein under 37 C.F.R. §1.57.

BACKGROUND OF THE INVENTION Field of the Invention

The disclosed embodiments relate to compositions, devices, and methodsrelated to promoting blood clotting.

Description of the Related Art

Blood is a liquid tissue that includes red cells, white cells,corpuscles, and platelets dispersed in a liquid phase. The liquid phaseis plasma, which includes acids, lipids, solubilized electrolytes, andproteins. The proteins are suspended in the liquid phase and can beseparated out of the liquid phase by any of a variety of methods such asfiltration, centrifugation, electrophoresis, and immunochemicaltechniques. One particular protein suspended in the liquid phase isfibrinogen. When bleeding occurs, the fibrinogen reacts with water andthrombin (an enzyme) to form fibrin, which is insoluble in blood andpolymerizes to form clots.

In a wide variety of circumstances, wounds can be inflicted as theresult of trauma. Often bleeding is associated with such wounds. In somecircumstances, the wound and the bleeding are minor, and normal bloodclotting functions in addition to the application of simple first aidare all that is required. First aid may include applying pressure to thewound with a sponge or similar device to facilitate clotting functions.Unfortunately, however, in other circumstances substantial bleeding canoccur. Bleeding can also be a problem when the trauma is the result of asurgical procedure. Apart from suturing or stapling an incision orinternally bleeding area, bleeding encountered during surgery is oftencontrolled using sponges or other materials used to exert pressureagainst the bleed site and/or absorb the blood. However, in manycircumstances these measures are not sufficient, such as when thebleeding becomes excessive, or when the wound is difficult to reach, orwhen it is advantageous to be able to view continuously the wound area.

SUMMARY OF THE INVENTION

Compositions comprising a clay, or a component of a clay, dispersed in aliquid medium can be useful as hemostatic or blood-clotting compositionsor agents. These compositions may be useful for promoting the clottingof blood for animals or human beings, including clotting blood inindividuals with a compromised ability to clot blood, such asindividuals taking anticoagulant drugs such as heparin, warfarin,clopidogrel, coumarin, etc., or individuals suffering from clottingdisorders such as Hemophilia A, Hemophilia B, von Willebrand disease,etc.

Some embodiments include a blood-clotting agent comprising: acomposition comprising clay dispersed in a liquid medium, wherein theclay is less than about 10% by weight of the composition; and whereinthe composition including the liquid medium and clay has a viscosity ofabout 1000 cP or less.

Some embodiments include a blood-clotting agent comprising: acomposition comprising clay dispersed in a liquid medium, wherein theclay is less than about 10% by weight of the composition; and whereinthe composition including the liquid medium and clay has a viscosity ofabout 1000 cP to about 100,000 cP.

Some embodiments include a hemostatic composition comprising: a claydispersed in an aqueous medium; wherein the composition is a liquidwhich is substantially free of visible clay particles; and wherein thecomposition is sterilized.

Some embodiments comprise a hemostatic composition comprising: kaolindispersed in an aqueous medium; wherein the composition is flowable;wherein at least 50% of the kaolin has a particle size in the range ofabout 1 nm to about 1000 nm; and wherein the composition is sterilized.

Some embodiments include a hemostatic device comprising: a vessel whichcontains a hemostatic composition of the type described herein; and adispensing component in fluid communication with the vessel; wherein thedevice is configured so that the dispensing component is capable ofdispensing the hemostatic composition from the vessel to a bleeding areaof an animal or person.

Some embodiments comprise a hemostatic composition comprising: a liquidcomprising a first component of a kaolin, wherein the first component ofthe kaolin is prepared by a process comprising: dispersing the kaolin inan aqueous medium; and separating the first component of the kaolin froma second component of the kaolin; wherein the first component of thekaolin has an average particle size which is smaller than an averageparticle size of the second component of kaolin.

Some embodiments include a hemostatic composition comprising: acomponent of kaolin dispersed in an aqueous medium; wherein thecomponent of kaolin is capable of remaining dispersed in the aqueousmedium for at least about 60 minutes without agitation.

Some embodiments include a hemostatic composition comprising: acomponent of kaolin dispersed in an aqueous medium; wherein thecomponent of kaolin is capable of remaining dispersed in the aqueousmedium for at least about 5 minutes in a centrifuge at a centripetalacceleration of at least about 1000 m/s².

Some embodiments include a blood-clotting composition comprising: a finekaolin having a reduced particle size as compared to a particle size ofa naturally and/or commonly occurring kaolin; and water; wherein thefine kaolin is dispersed in the water to form a stable kaolin-waterdispersion.

Some embodiments include a hemostatic system comprising: a hemostaticdevice comprising: a vessel comprising an interior volume configured tocontain a liquid; an orifice in fluid communication with the interiorvolume comprising a rim surrounding the orifice, wherein the rim isconfigured to form a seal, a removable adhesive connection, or a contactsurface with a part of an animal body or a human body; a fluid inputcomponent configured to provide a liquid to the interior volume of thevessel; and a fluid output component configured to allow liquid to exitthe interior volume of the vessel; and a composition of the typedescribed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a schematic example of a hemostatic device.

FIG. 2A depicts another schematic example of a hemostatic device.

FIG. 2B depicts another schematic example of a hemostatic device.

FIG. 3 depicts another schematic example of a hemostatic device.

FIG. 4 depicts another schematic example of a hemostatic device.

FIG. 5 is an expanded view of a portion of the example of a hemostaticdevice of FIG. 4.

FIG. 6A depicts an example of a system which may be used in applicationssuch as surgery.

FIG. 6B depicts another example of a system which may be used inapplications such as surgery.

FIG. 7 depicts an example of a hemostatic device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

As used herein, the term “hemostatic composition” is used in accordancewith the ordinary meaning in the art and includes a blood-clottingagent, a blood-clotting composition, a hemostatic composition, ahemostatic agent, or a similar material. A hemostatic composition maycomprise a clay or a component of a clay which may be dispersed in aliquid medium.

A liquid medium may include any liquid, including an aqueous liquid. Insome embodiments, the liquid medium may contain at least: about 10%,about 50%, or about 90% water by weight. Other liquids, includingorganic liquids, may be used. For example, alcohols such as glycerin,ethanol, methanol, isopropanol, and the like, may also be used. Acombination of non-aqueous liquids or a combination of water and otherliquids may also be used. In some embodiments, tap water, saline water,distilled water, or sterile water may be used.

A clay may include any clay such as kaolin, bentonite, montmorillonite,saponite, polygorskite or attapulgite, sepiolite, etc. In someembodiments, the clay may be a kaolin clay, which may include themineral “kaolinite.” The kaolin may include Edgar's plastic kaolin(hereinafter “EPK”), which is a water-washed kaolin clay that is minedand processed around Edgar, Fla.

A hemostatic composition may be prepared by adding an appropriate amountof clay to a liquid. This mixture may be used with these constituents bythemselves and/or without further treatment or processing (besidespossibly sterilization). In some embodiments, the mixture may besubjected to a separation process which may produce a separation of theclay into components or may provide clay particles in particular rangesof sizes. Thus, in some embodiments, one or more components orparticular size ranges of clay may be used in addition to or in place ofa native or standard type of clay. The component or particular sizerange of clay may be obtained by a separation process or may beseparately obtained and added to a liquid. As used herein, unlessotherwise indicated, the term “clay” should be understood to includeclay, a component of clay, or a combination thereof.

In some embodiments, a first component of a clay may be separated from asecond component of a clay. One or more separation processes may furtherprovide additional components of the clay, such as a third component, afourth component, etc. An example of a method that may be used toaccomplish a separation may be dispersing a clay in a liquid, and thenseparating the dispersion by filtration or using one or more settlingmethods such as centrifugation or standing.

A separation may produce a first component which is distinct from othercomponents in some way. Some separations involve separating a fractionwhich has more liquid from a fraction which has more solid, as comparedto the composition before the separation is carried out. A liquidfraction may include a supernatant, or the liquid portion removed fromthe top of a centrifuged mixture, or a filtrate, or the liquid which ispassed through a filter during a filtration. A solid fraction mayinclude the sediment or solid material from a centrifugation or thefiltered solid material obtained by filtration. In some embodiments, afirst component of a clay is separated from a second component of a clayby centrifuge or filtration.

In some embodiments, a first component may consist essentially of orinclude higher levels of ions of calcium (e.g. Ca⁺, Ca²⁺, etc.),aluminum (e.g. Al⁺, Al²⁺, Al³⁺, etc.), iron (e.g. Fe⁺, Fe²⁺, Fe³⁺, etc.)magnesium (e.g. Mg⁺, Mg²⁺, etc.), potassium (e.g. K⁺), sodium (e.g.Na⁺), or other ions. If the first component comprises a liquid fraction,this may be because the ions are soluble in the liquid, and thusretained with the liquid fraction. For example, the molar ratio of oneor more of these ions in a first component as compared to a secondcomponent may be at least about 1.1, about 2, or about 5 to about 10,about 100, or about 1000. Ions such as those listed above may also beadded directly to the composition.

In some embodiments, a first component may have an average particle sizewhich is smaller than the average particle size of a second component oranother component of the clay.

While a clay may be present in any amount, a clay may be at least: about0.00001%, about 0.001%, or about 0.01% by weight of the composition,and/or may further be about 10% or less, about 5% or less, or about 1%or less by weight of the composition. In some embodiments, a hemostaticcomposition may include clay particles of a size that renders thecomposition substantially free of visible clay particles to an observerwith an unaided eye. In some embodiments, the turbidity of thecompostion may be at least: about 0.001 Nephelometric Turbitidy Units(NTU), about 0.01 NTU, or about 0.3 NTU, and/or may further be about 5or less, about 50 or less, or about 200 or less. In some embodiments,the clay may be dispersed in a liquid to provide a stable clay-liquiddispersion, such as a stable clay-water dispersion or kaolin-waterdispersion. In some embodiments, an appreciable amount of the clayparticles may not settle from an aqueous liquid upon standing. In someembodiments, the clay particles may not settle from an aqueous liquidupon standing for at least about 5 minutes, at least about 1 hour, atleast about 12 hours, at least about 1 day, at least about 1 month, orat least about 1 year. In some embodiments, the clay particles may becapable of remaining dispersed in an aqueous liquid for at least about 1minute, at least about 5 minutes, at least about 30 minutes, or at leastabout an hour in a centrifuge at a centripetal acceleration of at leastabout 100 m/s, at least about 1000 m/s, or at least about 10,000 m/s.

A clay may have a particle size in a range that allows it to bedispersed in the liquid. For example, in some embodiments, at leastabout 50%, at least about 90%, or at least about 95% of a clay, such askaolin, may have a particle size in the range of about 1 nm to about 10μm, about 10 nm to about 5 μm, or about 50 nm to about 5 μm. In someembodiments, a fine clay may be used which has a reduced particle sizeas compared to a particle size of a naturally and/or commonly occurringclay. In some embodiments, the fine clay may be fine kaolin.

Tonicity agents may be included or omitted in a hemostatic compositionto adjust tonicity, for example, to make the composition isotonic,hypertonic, or hypotonic. Tonicity may be adjusted by adjusting theconcentration of a tonicity agent. For example, reducing theconcentration of a tonicity agent may reduce the tonicity of thecomposition, and increasing the concentration of a tonicity agent mayincrease the tonicity of the composition. Suitable tonicity agentsinclude, but are not limited to, sugars, such as glucose and isomersthereof, dextrose, fructose and isomers thereof, disaccharides, etc.;alkali salts (e.g. Group I salts), such as salts of Na⁺, K⁺, etc.;halide salts, such as salts of Cl⁻, BR⁻, I⁻, etc.; polyols such asglycerin and other sugar alcohols such as mannitol, sorbitol, etc.; etc.

A hemostatic composition may be sterile or sterilized. An antimicrobialagent may be included in some embodiments, which may help to preservethe sterility of a composition over time, or may help to improve orpreserve the sterility of the bleeding area while a hemostaticcomposition is used to promote clotting of a wound. Suitableantimicrobial agents may include, but are not limited to, compounds orsalts containing silver ions; compounds or salts containing copper ions;and halogen-based antimocrobials such as iodine, bromine, and chlorine,and salts or oxides thereof, such as ClO⁻, BrO⁻, IO⁻, etc. In someembodiments, the antimicrobial agent may comprise a stabilized halogenor halogen containing salt. One example of an antimicrobial agentincludes povidone (also known as polyvinylpyrrolidone) and/or iodine,such as a 10% povidone iodine solution.

A hemostatic composition may comprise a therapeutically active agent.Examples of therapeutically active agents may include, but are notlimited to, analgesics, including but not limited to, opiates such ascodeine, morphine, oxycodone, etc.; acetaminophen; anti-inflammatoryagents, including nonsteroidal anti-inflammatory drugs, aspirin, etc.;antibiotics or another antimicrobial drugs or compounds; antihistamines(e.g., cimetidine, chloropheniramine maleate, diphenhydraminehydrochloride, and promethazine hydrochloride); antifungal agents;ascorbic acid; tranexamic acid; rutin; thrombin; botanical agents; etc.;and combinations thereof. Other additives may include magnesium sulfate,sodium metaphosphate, calcium chloride, dextrin, and combinationsthereof.

A hemostatic agent may be in any form, such as a liquid, a gel, a paste,a foam, a cream, a particle, a powder, or other form. In someembodiments, a hemostatic composition may be flowable. For example, ahemostatic composition may have a viscosity from at least: about 0.1 cP,about 0.2 cP, about 0.5 cP, about 1 cP; and/or less than or equal to:about 1000 cP, about 10,000 cP, or about 100,000 cP. The viscosity mayvary according to the type of injury or situation in which thecomposition is used and/or the form of the composition. For example, insome embodiments, a liquid with a viscosity similar to water, such as aviscosity at or below about 1000 cP, about 100 cP, or about 10 cP, maybe desired for surgical applications. In some situations, such as intreating a wound formed by a bullet or another type of penetratingwound, a form of composition that is thicker or more viscous than watermay be used, such as a gel or foam, to allow the composition togenerally plug up or generally fill or generally obstruct or generallyimpede communication between the internal injured area and the areaoutside of the body to diminish the egress of blood from the wound andthe ingress of contaminants into the wound. The composition may, in someinstances, have much higher viscosities, such as at least: about 1000cP, about 10,000 cP, or about 50,000 cP; and/or less than or equal to:about 100,000 cP, about 150,000 cP, or about 250,000 cP.

For some forms of thicker or more viscous compositions, such as gels,pastes, foams, or other forms, a thickening agent, such as a gellingagent, may be added to increase the viscosity of the liquid. Thethickening agent may also help to keep a hemostatic agent such as a clayfrom settling from the dispersion. Any thickening agent may be used,including, but not limited to, cellulose derivatives such ascarboxymethylcellulose, hydroxypropylmethylcellulose, methylcellulose,hydroxypropylcellulose, etc.; other carbohydrates or polysaccharides, orderivatives thereof, such as dextrans, starches, starch derivatives,carrageenan, guar gum, gum karaya, xanthan gum, gum arabic, gumtragacanth, etc.; polycarboxylic acids such as polyacrylic acid,polymethacrylic acid, etc.; fatty acids such as myristic acid, palmiticacid, stearic acid, arachidic acid, and behenic acid, palmitoleic acid,oleic acid, linoleic acid, α-linolenic acid, γ-linolenic acid,arachidonic acid, eicosapentaenoic acid, etc.; polyalkylene glycolpolymers or copolymers such as polyethylene glycol, polyethyleneglycol-polypropylene glycol copolymers, etc.

A hemostatic composition may also contain cations such as calcium (e.g.Ca⁺, Ca²⁺, etc.), aluminum (e.g. Al⁺, Al²⁺, Al³⁺, etc.), iron (e.g. Fe⁺,Fe²⁺, Fe³⁺, etc.) magnesium (e.g. Mg⁺, Mg²⁺, etc.), potassium (e.g. K⁺),sodium (e.g. Na⁺), silver, etc.

A hemostatic composition may be applied to any bleeding area of ananimal or human being. Examples of injuries which may involve bleedingwhich could be treated with a hemostatic composition include, but arenot limited to, injuries related to surgery, injuries caused by a weaponsuch as a bullet, a blade such as a knife, sword or bayonet, anexplosive weapon, etc.

In some situations, such as in treating an injury characterized by agenerally long, generally tube-shaped bleeding hole (e.g., a bullettrack or an injury caused by a biopsy), treatment may be accomplished byapplying slightly more pressure to the infused hemostatic liquid thanthat of the exiting blood to position the hemostatic material at asuitable location within or proximate to the injury to assist indiminishing or halting bleeding. For example, the pressure may be atleast: about 180 mmHg, about 200 mmHg, about 250, about 300 mmHg; and/orless than or equal to: about 500 mmHg, about 700 mmHg, or about 1000mmHg. In some embodiments, the pressure may be about 300 mmHg.

The term “vessel” is used herein in accordance with its ordinary meaningin the art and includes any structure which is capable of holding ahemostatic composition and being in fluid communication with adispensing component. Examples may include, but are not limited to,containers such as bottles, vials, canisters, tubes, reservoirs, etc.,and materials which may hold the composition such as a sponge, a cloth,a gauze, etc. A dispensing component may be any feature which is capableof being in fluid communication with a vessel and dispensing ahemostatic composition from the vessel to a bleeding area of an animalor person. Examples may include, but are not limited to, valves, lumens,orifices, pumps, sponges, cloths, etc. In some embodiments, a hemostaticdevice may comprise an absorbent material, such as a sponge, cloth,gauze, etc., wherein a liquid hemostatic composition is absorbedtherein. The absorbent material may be saturated, meaning that thematerial cannot absorb any more liquid, or it may contain a liquidhemostatic composition but not be saturated. These devices may befurther packaged in a film or other sealing material to reduceevaporation or other loss of the liquid.

A hemostatic composition may be dispensed by and/or incorporated into ahemostatic device. FIG. 1 depicts a schematic example of an embodimentof a hemostatic device 110 which may comprise a vessel 120 whichcontains a hemostatic composition 130 and a dispensing component 140 influid communication with the vessel 120. In this example, the device isconfigured so that the dispensing component is capable of dispensing thehemostatic composition from the vessel to a bleeding area of an animalor person.

FIG. 2A depicts another example of an embodiment of a hemostatic device210. In this example, the vessel 220 may have a handle shape and maycontain a liquid hemostatic composition 230. The vessel 220 may beconnected to a dispensing component 240 comprising an absorbent materialsuch as a sponge, which may be applied directly to the bleeding area.

FIG. 2B depicts yet another example of an embodiment of a hemostaticdevice 215. In this example, the vessel 225 may comprise a cylinder andmay contain a liquid hemostatic composition 230. The vessel 225 may beconnected to a dispensing component 240 comprising an absorbent materialsuch as a sponge, which may be applied directly to the bleeding area.

FIG. 3 depicts another example of an embodiment of a hemostatic device310. In this example, a vessel and/or a dispensing component cancomprise a syringe 320. In some embodiments, the vessel and/ordispensing component can be in fluid communication with aspray-producing component 340. In some embodiments, the dispensingcomponent is a spray-producing component 340. The spray-producingcomponent 340 may be capable of dispensing the hemostatic composition ina form comprising a spray. The syringe 320 may further comprise areservoir cylinder 350 which may contain a liquid hemostatic composition330 and which may be in fluid communication with the spray producingcomponent 340. A plunger 360 may be slidably disposed within thereservoir cylinder 350. A user may apply force to the plunger 360 in thedirection 370 of the spray producing component 340 so as to applypressure to the liquid hemostatic composition 330 in the reservoircylinder 350, thus, forcing the liquid hemostatic composition 330through the spray producing component 340 to produce a spray of theliquid hemostatic composition 330.

FIGS. 4-5 depicts another example of an embodiment of a hemostaticdevice 410. In this example, the dispensing component may comprise afoam or spray producing component (referred to hereinafter as “spraycomponent”) 440. The spray component 440 may be capable of dispensingthe hemostatic composition in a form comprising a foam or spray. Thedevice may further comprise a propellant gas 450, which may fill theheadspace 460 above the liquid hemostatic composition 430 and bedissolved in the liquid 430 so that when the spray component 440 isopened, the pressure difference may cause foam or spray to be dispensed.The propellant gas dissolved in the liquid may provide foam or spray asthe dissolved gas expands under the reduced pressure. Inert gases, suchas nitrogen, carbon dioxide, and fluorocarbons, may be useful aspropellants.

As shown in FIG. 4, the spray component 440 may comprise a closed tube470, which may be closed at the top 475 and partially submerged belowthe surface of the liquid hemostatic composition 430. The spraycomponent may further comprise a cap 445, which may be movably connectedto the tube 470.

FIG. 5 depicts an expanded view of parts of the spray component 440which may allow the spray component to be opened so that the liquidhemostatic composition 430 may be dispensed. The tube 470 may comprisean orifice 510, and may be movably connected to a bottom platform 530 ofthe cap 445. The tube 470 may be further coupled to a spring 520 whichmay abut and may be supported by the bottom platform 530 of the cap 445.When the spring 520 and tube 470 are in a relaxed position, the orifice510 may be located just above a channel 540 in the cap 445. The channelmay be in fluid communication with an exit port 550, which may be influid communication with the outside of the device. When a user pushesthe tube 470 downward, the orifice 510 may become coupled to the channel540 to open fluid communication between the tube 470 and the channel 540so that the pressure from the propellant gas may force the liquidhemostatic composition 430 out of the exit port 550. When the liquidhemostatic composition 430 has been dispensed, the user may release theforce on the tube 470 so that the spring 520 may return the tube 470 tothe relaxed position.

A hemostatic composition may be incorporated into other systems ormethods in many different types of various applications, such assurgery. These methods or systems may comprise a hemostatic compositionin liquid form (or a “hemostatic liquid”) and a liquid provisioncomponent configured to provide the hemostatic liquid to an area of ahuman being or animal affected by a surgical procedure, such as an areathat is bleeding as a result of a surgical procedure. The liquidprovision component may be any structure, component, or device which iscapable of providing the hemostatic liquid to the area affected by asurgical procedure (e.g., through irrigation). For example, thehemostatic liquid may be provided during surgery, while surgery is beingcompleted, after surgery is completed, etc. . . . . Examples mayinclude, but are not limited to, surgical tubing with a hand piececomprising a valved dispensing portion to permit selective dispensing orirrigation. A system or method may further comprise a liquid-removalcomponent configured to remove liquids, such as the hemostatic liquid,blood, or other liquids, from the area of the human being or animalaffected by the surgical procedure (e.g., through aspiration). Theliquid-removal component may be any structure, component, or devicewhich is capable of removing liquid from the area affected by a surgicalprocedure. Examples may include, but are not limited to, tubing, such assurgical tubing. The liquid removal component may further be configuredto remove the hemostatic liquid while the surgery is taking place, assurgery is being completed, after surgery is completed, etc. Theliquid-delivery and liquid-removal components can be included togetheron a single hand piece or can be provided separately. An actuatorpositioned on the hand piece or surgical tubing can activate either orboth of the irrigation and aspiration features, or toggle between them.

FIG. 6A is a schematic of an example of a system which may be used inapplications such as surgery. In this example, a vessel 620 may be influid communication with an optional pump 610. The pump 610 may in turnbe in fluid communication with a first surgical tube 640, so that thepump 610 delivers the liquid hemostatic composition 630 through thefirst surgical tube 640 to provide hemostasis at the wound site and todeliver a hemostatic composition to a patient 650 who is undergoingsurgery. In this example, a second surgical tube 660 may also beprovided through which spent liquid hemostatic composition and otherliquids may be released into a waste receptacle 670. In somecircumstances, the pump may be omitted and circulation of the liquidhemostatic composition may be accomplished by other means. For example,the vessel 620 may be placed in a higher vertical position than thepatient 650, and the waste receptacle 670 may be placed in a lowervertical position than the patient so that gravity drives thecirculation.

FIG. 6B is a schematic of another example of a system which may be usedin applications such as surgery. In this example, a vessel 695 maycomprise a foam or spray producing component similar to spray component440 illustrated in FIGS. 4-5. Vessel 695 may be used to manually orperiodically deliver a liquid spray or foam of the hemostaticcomposition to a wound or opening 690 in a patient 650 who is undergoingsurgery. In this example, a second surgical tube 660 may also beprovided through which spent liquid hemostatic composition and otherliquids may be released into a waste receptacle 670. In somecircumstances, the waste receptacle 670 may be placed in a lowervertical position than the patient so that gravity drives thecirculation. Alternatively, suction may be applied through tube 660 toremove spent liquid hemostatic composition.

In some embodiments, a hemostatic system may comprise a hemostaticdevice that may comprise a vessel and a hemostatic composition. Thevessel may be any vessel which is configured to contain a liquid. Thisvessel may further comprise an interior volume configured to contain aliquid, and an orifice in fluid communication with the interior volumecomprising a rim surrounding the orifice, wherein the rim is configuredto generally provide contact with or to generally form a seal with apart of an animal body or a human body.

A rim may be a rim similar to a rim of a cup or a glass, or it maysimply be formed by a hole on an external surface of the vessel. It maybe even with an external surface of the vessel or may be raised withrespect to the surface of the vessel. In some embodiments, the rim maybe flexible or resilient. A seal may be formed by causing the rim to bepressed against the body part and/or by disposing an adhesive materialon the rim so that a seal is formed by temporary adhesion between therim and the body part.

A vessel may further comprise a fluid input component configured toprovide a liquid to an interior volume of the vessel. The fluid inputcomponent may be any structural feature or combination of features whichmay provide a liquid to an interior volume of a vessel, such as anorifice or a valve.

A vessel may further comprise a fluid output component configured toallow liquid to exit from the vessel. The fluid output component may beany structural feature or combination of features which may allow liquidto exit from the vessel, such as an orifice or a valve.

FIG. 7 depicts an example of a hemostatic device 700 that may be appliedto a bleeding area, open wound, or a surgical opening in the body. Thisexample may have an inverted vessel 705 having a closed top 710 and anopen bottom 720 having a rim 740. The bottom 720 may be placed on asurface 725 of an injured person or patient so that the rim 740 isgenerally proximate to and/or generally surrounds the injury or opening750. Pressure 760 may be applied to the device so that the rim 740 andthe surface 725 form a seal that generally obstructs or prevents liquidfrom escaping. In some embodiments, an adhesive material (not shown) maybe disposed on the rim 740 so that a seal is formed between the rim 740and the surface 725. A hemostatic composition 730 may be circulated byan inlet 770 through which the hemostatic composition 730 may enter thedevice and an outlet 780 through which the hemostatic composition 730and other fluid may exit the device 700.

Example 1

Kaolin (about 0.34 g) and glycerin (about 0.91 g) are mixed withsterile, distilled, non pyrogenic, pH 7.0 water (about 42 mL). Themixture appears cloudy or turbid.

Example 2

The mixture of Example 1 is centrifuged for about 5 minutes at about3000 rpm. The supernatant is carefully collected and the precipitate isdiscarded to yield a liquid hemostatic composition which appearssubstantially clearer.

Example 3

The composition of Example 2 (about 3 mL) is combined with 10% povidoneiodine (about 3 mL).

Example 4

The composition of Example 2 (about 6 mL) is combined with 10% povidoneiodine (about 3 mL).

Example 5

The compositions prepared as described in Examples 1-3, and water weretested for clotting. The test was carried out by combining 0.5 ml of thehemostatic composition with 1 ml of citrated sheep blood and 150 μL ofCaCl₂ in a test tube.

The clotting times for the four samples are shown in Table 1 below.

TABLE 1 Clotting Time Composition (Min:Sec) Example 1 1:30 Example 21:45 Example 3 2:45 Example 4 2:30 Water 6:30

Although the embodiments have been described in the context of certainexamples, it will be understood by those skilled in the art that thescope of the claims may extend beyond the specifically disclosedembodiments to other embodiments including embodiments formed ofcombinations of features disclosed herein and equivalents thereof.

The following is claimed:
 1. A hemostatic device comprising: anabsorbent material; a composition comprising a clay hemostatic agent anda thickening agent; wherein the clay hemostatic agent is kaolin; whereinthe thickening agent comprises one or more of carboxymethylcellulose,hydroxypropylmethylcellulose, methylcellulose, andhydroxypropylcellulose; and wherein the composition is suspended in anaqueous liquid and absorbed onto the absorbent material duringpreparation of the hemostatic device.
 2. The hemostatic device of claim1, wherein the clay hemostatic agent comprises about 10% or less of theweight of the suspension in aqueous liquid.
 3. The hemostatic device ofclaim 1, wherein the absorbent material is selected from the groupconsisting of a sponge, a cloth, and a gauze.
 4. The hemostatic deviceof claim 1, wherein the absorbent material is a gauze.
 5. The hemostaticdevice of claim 1, wherein the composition further comprises one or moreof bentonite, montmorillonite, saponite, polygorskite, attapulgite, andsepiolite.
 6. The hemostatic device of claim 1, wherein the thickeningagent is a gelling agent.
 7. The hemostatic device of claim 1, whereinthe thickening agent comprises hydroxypropylmethylcellulose.
 8. Thehemostatic device of claim 1, wherein the thickening agent comprisescarboxymethylcellulose.
 9. The hemostatic device of claim 1, wherein thehemostatic device is dry.
 10. The hemostatic device of claim 1, whereinthe hemostatic device is provided in a sterilized package.
 11. A methodfor treating a bleeding injury, the method comprising: applying ahemostatic device to a wound site, the hemostatic device comprising: anabsorbent material; and a composition comprising a clay hemostatic agentand hydroxypropylmethylcellulose; wherein the clay hemostatic agent iskaolin; wherein the composition is suspended in a liquid to form asuspension; and wherein the suspension is absorbed onto the absorbentmaterial during preparation of the hemostatic device.
 12. The method ofclaim 11, wherein the bleeding injury is a traumatic injury.
 13. Themethod of claim 11, wherein the bleeding injury is caused by a bullet,an explosive, a blade, or during a medical procedure.
 14. The method ofclaim 11, wherein the bleeding injury is caused by surgery.
 15. A methodfor manufacturing a hemostatic device, the method comprising: applying aclay hemostatic agent to an absorbent material; applying a thickeningagent the absorbent material; wherein the clay hemostatic agent iskaolin; wherein the thickening agent comprises one or more ofcarboxymethylcellulose, hydroxypropylmethylcellulose, methylcellulose,and hydroxypropylcellulose; and wherein the clay hemostatic agent issuspended in an aqueous liquid and absorbed onto the absorbent materialduring preparation of the hemostatic device.
 16. The method of claim 15,wherein the thickening agent is applied to the absorbent material as aliquid suspension.
 17. The method of claim 15, wherein the thickeningagent is also suspended in the aqueous liquid and absorbed onto theabsorbent material during preparation of the hemostatic device.
 18. Themethod of claim 15, further comprising a step of drying the absorbentmaterial after application of the clay hemostatic agent and thethickening agent.
 19. The method of claim 15, wherein thickening agentcomprises hydroxypropylmethylcellulose.
 20. The method of claim 15,wherein thickening agent comprises carboxymethylcellulose.